Is BPC-157 Legal? FDA Status, Category 2 & What It Means in 2026
Published March 1, 2026
BPC-157 Legal Status: The Short Answer
BPC-157 (Body Protection Compound-157) exists in a regulatory gray area that shifted significantly in 2025. Here is the current status as of early 2026:
- BPC-157 is not a controlled substance in the United States
- BPC-157 is not FDA-approved for any medical condition
- The FDA placed BPC-157 on its Category 2 bulk drug substances list in 2025, prohibiting its use in compounded medications
- BPC-157 remains available as a research chemical
- BPC-157 is banned by WADA and USADA in competitive sports
For the broader peptide regulatory landscape, see our Are Peptides Legal? guide and FDA Peptide Regulations 2026 overview.
What Is the Category 2 Decision?
The Category 2 classification is the most consequential regulatory development for BPC-157 to date.[1]
FDA Bulk Drug Substance Categories
- Category 1: Approved for use in compounding
- Category 2: Evaluated and rejected for compounding use
- Category 3: Still under evaluation
In 2025, the FDA moved BPC-157 to Category 2, concluding that insufficient safety and efficacy data existed to support its use in compounded medications. The Pharmacy Compounding Advisory Committee determined that no adequate human safety data existed, published research was predominantly animal studies, and the risk-benefit profile could not be adequately assessed.
What Category 2 Actually Changes
What Changed
- 503A and 503B pharmacies should no longer compound BPC-157 into prescriptions
- Physicians cannot legally prescribe compounded BPC-157 from compliant pharmacies
- Telehealth peptide clinics must discontinue BPC-157 prescribing
What Did Not Change
- Research chemical sales are not directly affected by the Category 2 decision
- Personal possession is not a federal crime (BPC-157 is not a controlled substance)
- International availability varies by jurisdiction. See our UK legality guide
The Research Chemical Pathway
Most BPC-157 currently available in the US is sold as a research chemical with "not for human consumption" labeling. This has specific implications:
- Legitimate research institutions can legally purchase and use BPC-157
- Individual purchasers operate in a legal gray area — the substances are not illegal but sellers disclaim human use
- Quality varies significantly between sources since research chemicals are not subject to pharmaceutical manufacturing standards
- FDA enforcement primarily targets sellers making therapeutic claims, not individual purchasers
Sports Anti-Doping Status
For athletes, BPC-157's status is unambiguous:[2]
- WADA: Prohibited at all times under S0 (Non-Approved Substances)
- USADA: Follows WADA rules; 4-year suspension for first offenses
- NCAA and professional leagues: Prohibited under similar categories
International Legal Comparison
| Jurisdiction | Status | Compounding? | Notes |
|---|---|---|---|
| United States | Not controlled; Category 2 | No (since 2025) | Research chemical available |
| United Kingdom | Not controlled | Limited | Personal import tolerated |
| Australia | Schedule 4 (prescription) | Yes, with prescription | Peptide clinics active |
| Canada | Not approved | Gray area | Health Canada has not addressed |
| EU | Varies by state | Varies | Generally research use only |
What Comes Next?
- Formal human clinical trials could eventually lead to FDA approval
- Compounding industry legal challenges may affect Category 2 determinations
- Some states have taken independent positions on peptide compounding
- International regulatory approvals could influence the US landscape
For the complete BPC-157 research profile, visit our BPC-157 hub page. For dosing, see the BPC-157 Dosage Guide.
Researching peptides? We did the hard part.
Get our free Peptide Starter Kit — the 5 most researched compounds, simplified into one actionable guide.
Frequently Asked Questions
References
- FDA. Bulk Drug Substances Used in Compounding Under Section 503A. FDA.gov, 2025.
- WADA. 2025 Prohibited List. WADA-AMA.org, 2025.
- Sikiric P, et al.. Stable gastric pentadecapeptide BPC 157: novel therapy in gastrointestinal tract. Current Pharmaceutical Design, 2011.
Related Articles
Peptides Insider Editorial Team
Our content is reviewed for accuracy and grounded in peer-reviewed research where available. We do not provide medical advice. Always consult a qualified healthcare professional.